Clinical Research Director

3 weeks ago

Jupiter, Florida, United States CRO Strategies Full time
{"title": "Principal Investigator - Clinical Research", "subtitle": "Lead Clinical Research Studies and Ensure Scientific Integrity", "content": "

At CRO Strategies, we are seeking a highly experienced Principal Investigator to lead our clinical research studies and ensure the highest standards of scientific integrity, regulatory compliance, and patient safety.

This is a unique opportunity to work on cutting-edge research and make a significant impact in the field of medicine.

The successful candidate will have a strong background in clinical trials, a deep understanding of regulatory requirements, and a passion for advancing medical knowledge.

Key Responsibilities:

  1. Study Leadership and Management:
  • Supervise and mentor research staff, including Clinical Research Coordinators, Data Managers, and other support personnel.
  1. Regulatory Compliance:
  • Ensure compliance with all regulatory requirements, including FDA regulations, ICH-GCP guidelines, and institutional policies.
  • Prepare and submit regulatory documents, including IRB applications and protocol amendments.
  • Conduct regular audits and quality control checks to ensure data integrity and protocol adherence.
  1. Patient Safety and Care:
  • Monitor patient safety and welfare throughout the study, including adverse event reporting and resolution.
  • Provide informed consent to study participants and ensure they understand their rights and responsibilities.
  • Address and resolve any issues related to patient care and safety.
  1. Data Management and Analysis:
  • Oversee data collection, management, and analysis to ensure accuracy and reliability.
  • Interpret study results and prepare comprehensive reports and publications for dissemination.
  • Collaborate with biostatisticians and data analysts to evaluate study outcomes.
  1. Collaboration and Communication:
  • Work closely with sponsors, CROs, and other stakeholders to ensure the successful execution of clinical trials.
  • Represent the research site at meetings, conferences, and other professional events.
  • Maintain effective communication with all study team members and stakeholders.

Qualifications:

  • Education: MD, DO, or PhD in a relevant medical or scientific field.
  • Experience: Minimum of 5 years of experience in clinical research, including experience as a Principal Investigator.
  • Certifications: Board certification in Internal or Family Medicine
  • Skills:
  • Extensive knowledge of clinical research methodologies and regulatory requirements.
  • Strong leadership, organizational, and communication skills.
  • Ability to analyze complex data and prepare detailed reports.
  • Proficiency in electronic data capture systems and other research software.

Why Work with Us:

  • Competitive salary and benefits package.
  • Opportunity to lead cutting-edge research and make a significant impact in the field of medicine.
  • Collaborative and supportive work environment with opportunities for professional growth and development.
  • Beautiful location in Jupiter, FL, offering a high quality of life and a great work-life balance.
"}

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